
24/07/2025
Outstanding clinical trial results in metastatic and advanced oestrogen positive (ER+) HER2 negative breast cancers that shows prolonged progression free survival.
ASCO 2025 New drug target for metastatic / advanced Hormone Receptor Positive Breast Cancer
INAVO Phase III International randomised double -blind placebo-controlled trial
Metastatic and advanced hormone receptor positive (HR+) HER2 negative breast cancers acquire treatment resistance to endocrine treatments such as: Cyclin Dependent Kinase Inhibitor or CDKI (Palbociclib) and Faslodex (selective oestrogen receptor degrader or SERD).
Circulating cancer DNA or tissue DNA is used to measure a key treatment target called a PIK3CA mutation that occurs in 40% of patients.
Inavolisib targets PIK3CA to produce significant increases in cancer Progression Free Survival from 7 months (placebo) to 17 months (Inavolisib) over 34 months, when combined with Palbociclib and Faslodex.
Objective cancer response rates are significantly higher from 28% (placebo) to
63% (Inavolisib), with a duration of response from 11 months (placebo) to 19 months (Inavolisib).
See link: https://pubmed.ncbi.nlm.nih.gov/39476340/
In patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer, inavolisib plus palbociclib-fulvestrant led to significantly longer progression-free survival than placebo plus palbociclib-fulvestrant, with a greater incidence of toxic ef...